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Site Master File : ウィキペディア英語版 | Site Master File
Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer.〔(【引用サイトリンク】title=SMF: PIC/S explanatory notes )〕 ==About== A site master file is a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.〔(【引用サイトリンク】title=WHO: Guidelines for drafting a Site Master File )〕
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Site Master File」の詳細全文を読む
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